Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
- Conditions
- MelanomaSkin CancerAnxiety and Fear
- Interventions
- Device: 2D or 3D Melanoma Surveillance Photography
- Registration Number
- NCT04385732
- Lead Sponsor
- Melanoma and Skin Cancer Trials Limited
- Brief Summary
This randomised controlled trial will investigate the role of melanoma surveillance photography (MSP) in the surveillance of patients at high or ultra-high risk of melanoma. MSP is a comprehensive method of melanoma monitoring which includes total body photography and digital dermoscopy which is performed at prescribed intervals. The study will test whether participants under surveillance with MSP have less unnecessary biopsies (false positives) compared to those without MSP. Participants will be Australian residents with a new diagnosis of primary melanoma, who have multiple naevi and are at high or ultra-high risk of developing melanoma. Participants will be randomised 1:1 to either groups.
It is hypothesised that those randomised to surveillance with MSP will have better patient outcomes. Improved diagnostic performance as measured by the number of unnecessary biopsies will be the primary outcome measure.
- Detailed Description
The primary aim is to test whether melanoma surveillance with MSP, comprising either 2D or 3D TBP tagged with digital dermoscopy, compared to clinical surveillance without MSP, results in improved diagnostic performance, specifically reduced number of unnecessary biopsies (i.e. false positives due to an excision or biopsy of a lesion being performed to diagnose melanoma and that lesion being identified on pathology as benign), in high (and very high) risk individuals whose risk is contributed to by high naevus counts.
The secondary aims are to:
1. Evaluate whether MSP:
1. Results in improved sensitivity of doctors' diagnosis of melanoma (i.e. reduction in false negatives)
2. Improves health-related quality of life, patient satisfaction, and reduces patient anxiety
3. Reduces costs to patients and health care system
2. Evaluate the safety and acceptability of MSP
3. Evaluate benefit of MSP in high risk patients prior to a primary melanoma diagnosis (Sub-study 1)
4. Evaluate diagnostic performance of tele-dermatology compared to en-face clinical visits (Sub-study 2).
Investigators hypothesise that for ultra-high and high risk patients with multiple naevi, clinical surveillance with melanoma surveillance photography (compared to without MSP) will lead to better patient outcomes, in particular a reduction in the number of unnecessary biopsies (i.e. false positives) as a measure of diagnostic performance. Secondary hypotheses include that for ultra-high, and high risk patients with multiple naevi, clinical surveillance with MSP (compared to without MSP) will lead to:
1. Reduction in the number of misclassified melanoma malignancies (i.e. false negatives);
2. Reduction in the number of misclassified melanocytic and keratinocyte lesions combined;
3. Improved quality of life; and
4. Favourable health economic outcomes.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 670
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care plus Melanoma Surveillance Photography 2D or 3D Melanoma Surveillance Photography Clinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy.
- Primary Outcome Measures
Name Time Method Diagnostic performance of melanoma surveillance 24 months The primary outcome is the diagnostic performance of surveillance for melanoma, expressed as the number of false positive biopsies per patient over a 24-month period.
- Secondary Outcome Measures
Name Time Method Diagnostic performance for melanoma 24 months Agreement and reliability indices.
Patient anxiety 24 months European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Fear of Cancer Recurrence - short form (FCR4) and a purpose-designed patient acceptability scale will be utilised to synthesise a single endpoint measure for patient anxiety. Value range is 0 to 100, where higher values represent greater anxiety (worse outcomes).
Cost-effectiveness of MSP 24 months Standard health economic cost-effectiveness measures.
Diagnostic performance for keratinocyte lesions 24 months Agreement and reliability indices.
Health-Related Quality of life 24 months Assessment of Quality of Life (AQOL-8D) questionnaire for calculation of quality-adjusted life years (QALYs). Minimum score per each of 8 questions is 1; maximum score is 5, where higher score represents worse outcomes. Scores may be aggregated to provide an overall index of the health state utility per participant, where higher scores indicate worse quality of life outcomes.
Trial Locations
- Locations (12)
Skin Health Institute
🇦🇺Carlton, Victoria, Australia
Wonthaggi Hospital, Bass Coast Health
🇦🇺Wonthaggi, Victoria, Australia
Newcastle Skin Check
🇦🇺Newcastle, New South Wales, Australia
Dermatology Clinical Trials Unit, Westmead Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Melanoma Institute Australia
🇦🇺Wollstonecraft, New South Wales, Australia
Skin Repair Skin Cancer Clinic, Townsville
🇦🇺Townsville, Queensland, Australia
Victorian Melanoma Service, Alfred Health
🇦🇺Melbourne, Victoria, Australia
FNQH Cairns Skin Cancer Centre
🇦🇺Cairns, Queensland, Australia
Diamantina Institute, University of Queensland
🇦🇺Brisbane, Queensland, Australia
Bendigo Cancer Centre Research Unit, Bendigo Health
🇦🇺Bendigo, Victoria, Australia
Phillip Island Health Hub, Bass Coast Health
🇦🇺Cowes, Victoria, Australia